Effect of Rehabilitation at Moderate Altitude on Airway Resistance Measured With Forced Oscillation Technique in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- 1. Change in Rrs (Respiratory System Resistance) before and after rehabilitation cycle
研究概览
简要总结
Airway resistance will be measured using the forced oscillation technique (FOT). The parameters Rrs, Xrs, and ∆Xrs will be compared before and after a pulmonary rehabilitation cycle at moderate altitude. Additionally, the differences between low and moderate altitude will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Stable clinical condition for >3 weeks (e.g., no exacerbations)
- •Resting SpO₂ ≥88% and exercise-induced hypoxemia defined as a drop in SpO₂ of ≥4% and/or a level below 90% during the 6MWT
- •Informed consent documented by signature
排除标准
- •Severe daytime resting hypoxemia (SpO₂ <88%)
- •Long-term oxygen therapy
- •Unstable clinical condition requiring adjustment of pharmacological or other treatment modalities, need for intensive care, or presence of relevant severe comorbidities
- •Inability to comply with study procedures (e.g., due to language barriers, psychological disorders, neurological or orthopedic impairments, walking disability, or inability to ride a bicycle)
- •Women who are pregnant or breastfeeding
- •Enrolment in another clinical trial involving active treatment
研究组 & 干预措施
Normoxia
Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFlo TM via nasal cannula
干预措施: ambiant air (Other)
Hypoxia
This group will train at moderate altitude
干预措施: ambiant air (Other)
Hyperoxia
Standardized supplemental oxygen therapy (SSOT) at 5 L/min will be delivered using the EverFlo™ oxygen concentrator via nasal cannula during training.
干预措施: Oxygen (Other)
结局指标
主要结局
1. Change in Rrs (Respiratory System Resistance) before and after rehabilitation cycle
时间窗: baseline to 3 weeks
Rrs will be measured using the forced oscillation technique (FOT) in cmH₂O·s/L. Values will be assessed before and after the pulmonary rehabilitation cycle at moderate altitude
次要结局
- Change in Xrs (Respiratory System Reactance) compared before and after the pulmonary rehabilitation.(baseline to 3 weeks)
- Change in ∆Xrs (Difference in Reactance) before and after rehabilitation(baseline to 3 weeks)
- Change in Rrs, Xrs and ∆Xrs from low to moderate altitude(From baseline at low altitude to transfer to moderate altitude at 3 days)